Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria.
Department of Neurology, Medical University of Vienna, Vienna, Austria.
Mult Scler Relat Disord. 2022 Jul;63:103810. doi: 10.1016/j.msard.2022.103810. Epub 2022 Apr 20.
Background Alemtuzumab (ATZ), a highly effective disease modifying treatment for relapsing multiple sclerosis (MS), is associated with the rare risk of intracerebral hemorrhage. Increase of blood pressure (BP) was hypothesized to be causative, but prior administration of high-dose methylprednisolone (HDMP) is a potential confounder. Objective To analyze BP change in MS patients treated with ATZ and prior HDMP treatment compared to patients receiving HDMP only for acute relapse. Methods In this retrospective study, 30 patients treated with ATZ/HDMP and 60 age-, sex- and disability-matched controls treated with HDMP were included. Primary endpoint was the change of systolic BP (SBP) between before ATZ cycle and the maximum value measured during the treatment cycle; secondary endpoints were change in diastolic BP (DBP) and heart rate (HR). Results Change of SBP observed in ATZ/HDMP treated patients was significantly higher than in HDMP controls (mean maximal change of 12.8 vs. 8.1 mmHg, p = 0.033). An increase of SBP exceeding 20% from baseline was observed in 5 (16.7%) patients on ATZ/HDMP compared to 3 (5.0%) on HDMP (p = 0.078). The day after the 1st ATZ infusion, mean HR was higher in the ATZ/HDMP group compared to HDMP controls (82.5 vs. 73.2 bpm, p = 0.005), although there was no significant group difference over time. Conclusions ATZ treatment induced a slight, but significant increase in SBP independent of HDMP. Although hemodynamic alterations alone seem unlikely as putative mechanism for cerebral bleedings, strict cardiovascular monitoring is recommended to reduce rare, but severe cardiovascular side effects.
阿仑单抗(ATZ)是一种治疗多发性硬化症(MS)的高效疾病修正治疗药物,与颅内出血的罕见风险相关。据推测,血压(BP)升高是其致病因素,但先前给予大剂量甲基强的松龙(HDMP)是一个潜在的混杂因素。目的:分析与仅接受 HDMP 治疗急性复发的 MS 患者相比,接受 ATZ/HDMP 治疗的 MS 患者的 BP 变化。方法:在这项回顾性研究中,纳入了 30 例接受 ATZ/HDMP 治疗的患者和 60 例年龄、性别和残疾相匹配的仅接受 HDMP 治疗的对照者。主要终点是 ATZ 周期前后收缩压(SBP)的变化与治疗周期内测量的最大值之间的差异;次要终点是舒张压(DBP)和心率(HR)的变化。结果:ATZ/HDMP 治疗患者的 SBP 变化明显高于 HDMP 对照组(平均最大变化 12.8 比 8.1mmHg,p=0.033)。5 例(16.7%)ATZ/HDMP 治疗患者的 SBP 从基线升高超过 20%,而 HDMP 对照组为 3 例(5.0%)(p=0.078)。在第 1 次 ATZ 输注后的第 1 天,ATZ/HDMP 组的平均 HR 高于 HDMP 对照组(82.5 比 73.2bpm,p=0.005),尽管随时间的推移两组间无显著差异。结论:ATZ 治疗会引起轻微但显著的 SBP 升高,与 HDMP 无关。尽管单独的血流动力学改变不太可能是导致脑出血的潜在机制,但建议进行严格的心血管监测,以减少罕见但严重的心血管副作用。